# K982761: Joint Motion Device Package PN 1032,Kneel Cervical PN 1026, Lumbar 1027, Wrist 1028, Ankle 1029, Shoulder 1030, Hip 1031

- Pathway: 510(k) (Traditional)
- Applicant: Chamco, Inc.
- Decided: Oct 22, 1998 after 77 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953918 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953918: Magnetic Resonance Diagnostic Device, Hitachi Medical Systems America, Inc. (1995) Summary page 2.

## Indications for use
The Joint Motion Devices are an accessory to MRI diagnostic devices, including the Hitachi AIRIS™, Siemens Magnatom™, Toshiba OPART™, Picker Outlook™, Fonar, and GE Medical Systems Open MRI systems. In addition, the devices may be used in any MRI system where the physical limits of the bore size is not a constraint. The devices are built from plastics and nonferromagnetic materials, and hold patients securely during MRI imaging sequences. The devices also constrain joint motion to one of several user-designated planes of rotation, dependant upon the joint to be imaged, and emulate the natural motion of the joint. The Joint Motion Devices increase the clinical utility of MRI systems to provide high quality, repeatable imaging and constraint for the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies to enable fixed position imaging, and kinematic (incremental stepped) motion of the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies, and dynamic (continuous) motion of the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder joint anatomies. The devices will enable the physician to evaluate the anatomy of the knee, cervical spine, ankle, wrist, lumbar spine, hip and shoulder anatomies, in a static mode as well as to evaluate the dynamic interaction of the different tissues (ligaments, cartilage, bone, muscle, fat). Such functional interaction may be useful in diagnosis. The intended patients are primarily drawn from a pool of those subjects undergoing diagnostic evaluation by physicians who are skilled in diagnosis and treatment of the disease processes under consideration.

Source page: https://510kreport.com/device/K982761
Methodology: https://510kreport.com/methodology